U.S. FDA Could Drop CBD Guidance ‘Within Months’
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The U.S. Food and Drug Administration is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements, the Wall Street Journal reported, citing agency officials.
After weighing the evidence on the compound’s safety, the FDA will decide within months how to regulate legal cannabis and whether that will require new agency rules or new legislation from Congress, according to the report.
In an interview, Janet Woodcock, the FDA’s Deputy Commissioner and leader of the agency’s cannabis regulation efforts, expressed concern about the safety of CBD and whether current regulatory pathways for food and dietary supplements are suitable for this substance.
However, the agency is interested in determining whether it is safe to consume CBD on a daily basis for extended periods of time or during pregnancy.
Woodcock mentioned concerns about potential effects on fertility in the future, but, at the same time, her comment signaled that the agency is working to establish regulatory frameworks for the legal sale of appropriate cannabis and cannabis-derived products.
CBD is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.
The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the market for CBD products. These products, sold as dietary supplements, are believed to have health benefits. As a result, many businesses in the cannabis industry are now selling CBD products across the country.
In recent months, the FDA posted warning letters to at least nine companies for illegally selling products containing CBD. The companies are accused of selling products containing CBD that the FDA states some people may confuse for traditional foods or beverages that do not contain CBD or were making medical claims about their CBD products.
In 2021, The FDA told Charlotte’s Web Holdings Inc., one of the world’s largest CBD companies, that its cannabidiol product cannot be sold as a dietary supplement, signaling that CBD reform may have to wait for congressional action.
The FDA has not approved any CBD-based products for use as dietary supplements. The only CBD-based product the FDA has approved is Epidiolex, a prescription medication used to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in children two years of age and older.
